Sanofi Recalls Regular Strength Zantac 75 mg Due to NDMA Impurity
Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 75 mg tablets because the FDA detected the NDMA impurity in the product.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' severity score under the rubric, particularly given the presence of a known carcinogenic impurity (NDMA).
Plain-English summary
Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 75 mg tablets, distributed by Chattem, Inc. The recall covers all lots of the product, specifically NDCs 67751-152-01 and 67751-152-02. The product was distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. The FDA has classified this recall as Class II.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatments or disposal.
The recalled product
- Product
- Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 67751-152-01 67751-152-02
- Manufacturer
- Sanofi-Aventis U.S. LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Sanofi-Aventis U.S. LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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